Degenerative osteoarthritis of the first carpal-metacarpal joint (basal joint) of the thumb is a common, disabling condition, especially in middle-aged women. Investigations show that about 25% of all women and 8% of men in their fifties complain of pain at the base of the thumb, secondary to osteoarthritis. This condition causes joint instability and subluxation, due to incompetence of an important stabilizing structure, the volar oblique ligament, resulting in dorsal subluxation, adduction contracture, and subsequent compensatory metacarpal-phalangeal joint hyperextension deformity. As arthritis progresses, patients suffer from load-related pain, affecting pinching and gripping activities, and experience weakness, severe dysfunction, reduced mobility, and loss of functionality. Several methods of basal joint reconstruction have been proposed, most of which involve some form of soft tissue reconstruction which have historically involved harvesting tendons which are subsequently transferred and re-directed via drill holes in the thumb metacarpal to restore proper balance, alignment, and prevent cantilever displacement forces at the base of the thumb. These methods involve harvesting and thereby sacrificing an entire or a portion of a functioning tendon, which is utilized to create a suspension and stabilization of the basal joint. Many of the past described surgical methods require temporary pin fixation of the joint, subsequent pin removal and have been associated with pin tract complications, such as infection, nerve damage, neuroma formation, and these methods which utilize more extensive and often multiple incisions cause increased surgical morbidity. One method simply involves removing the arthritic articulation by excising the trapezium and temporarily pinning the joint in distraction. This procedure can provide pain relief, but is associated with persistent collapse deformity, proximal migration, and weakness. The key principles of successful basal joint arthroplasty involve trapezial excision, which is required for pain relief, and some form of ligament reconstruction, which restores the function of the important volar stabilizing ligament, thereby re-creating the proper balance, alignment, longitudinal length, and function of the thumb. With ligament reconstruction, not only is pain relief attained but strength, alignment and stability are achieved.
Several methods of artificial joint replacement have been utilized including those made of silicone, metal/plastic with cemented or non-cemented implants, and more recently, synthetic fabrics for interposition. Each of these methods have had significant failure rates and complications related to implant failure, fracture of the bone interfaces, particulate synovitis, dislocation and loss of stability over time. Revision rates have been high with the prosthetic implants, most of which have not addressed the concept of ligamentous reconstruction and re-creation of the important function of the volar oblique ligament, which appears to be essential for restoring proper balance and function to the reconstructed basal joint. Additional problems with the recently developed synthetic fabric inserted into the basal joint include irritation over the synthetic fabric, which is secured to the dorsal base of the thumb metacarpal, potential fixation problems, as well as the fact that the synthetic fabric design only addresses the distal articular surface of the basal joint, leaving the proximal joint (scaphoid-trapezial joint) interface intact. This particular form of synthetic implant is limited in use for patients with very early arthritis, involving only the distal carpal-metacarpal joint and is not appropriate for the larger cohort of arthritic patients who suffer from arthritis in a more extensive, pan-trapezial (surrounding the trapezium on all articular surfaces) fashion.
The various techniques employed in basal joint arthroplasty have recently been the subject of discussion in several medical journals. “Basal Joint Arthritis of the Thumb” has been reviewed by Michael S. Shuler, Shai Luria, and Thomas E. Trumble in the Journal of the American Academy of Orthopaedic Surgeons 2008; 16: 418-423, which is hereby incorporated by reference. “CMC Arthroplasty of the Thumb: A Review” has been reviewed by Kristofer S. Matullo, Asif Hyas, and Joseph J. Thoder in Hand (2007) 2: 232-239, which is hereby incorporated by reference. “Basal Joint Arthroplasty: Indications and Treatment” has been reviewed by Steven Z. Glickel and Landon T. Home in Current Opinion in Orthopaedics 2001, 12: 290-294, which is hereby incorporated by reference.
One of the methods frequently utilized, the Ligament Reconstruction, Tendon Interposition technique, (LRTI) involves sacrificing the flexor carpi radialis tendon, either in whole or in part. This technique requires one or two additional forearm incisions to harvest a wrist flexor tendon, formation of a drill hole within the metacarpal base to re-direct the tendon reconstruction, rolling up the remaining tendon which is placed into the arthroplasty space, pinning the joint for 4-6 weeks, and immobilization in a post-operative cast for 4-6 weeks, after which thumb/wrist orthotics are utilized and hand therapy is instituted for 2-3 months. Typical return to normal activities can be expected in about 6 months to a year. Long term results have been excellent with regard to pain relief, but the healing process is lengthy, incisions are extensive and multiple, subsidence with loss of arthroplasty space has been reported, pin tract complications do occur, aid the technique is technically demanding, lengthy and requires sacrificing a normal, functioning wrist flexor tendon.
One method for treatment of basal joint arthritis is a simple excision of the trapezium and pinning the joint in slight distraction with the pin removed at 4-6 weeks post-operative. This technique does not address ligament reconstruction to restore function of the incompetent volar oblique ligament, and includes the disadvantages and risks of pin fixation. Collapse of resection arthroplasty space (subsidence), persistent dorsal subluxation, persistent adduction contracture, and compensatory metacarpal-phalangeal joint hyperextension deformity is common, but pain relief is reported to be satisfactory. This technique may not be appropriate for younger, higher demand patients.
Another method for soft tissue reconstruction that has been disclosed in the American Society for Surgery of the Hand Correspondence Newsletter, 2004-52, DelSignore, August, 2004, which is hereby incorporated by reference, involves a modification of the Weilby technique, by utilizing an ulnarly based slip of the abductor pollicis longus tendon, and avoids the need for drill holes to redirect the tendon, avoids the need for pin fixation, and requires only 4 weeks of cast immobilization, with typical return to heavy manual activities for the majority of patients at 3 months (12 weeks) post operative. This technique utilizes only one distally based slip of the abductor pollicis longus tendon which does not sacrifice it's function, but does require an incision that extends proximal to the wrist flexion crease and can be associated with some residual wrist stiffness, as wrist immobilization is recommended for four weeks post-operatively which can result in a longer period of recovery of wrist and hand motion. Patients may experience some temporary and rarely permanent irritation of the dorsal sensory branch of the radial nerve, as the incision does cross the wrist flexion crease in a proximal and radial direction, requiring very careful identification and retraction of branches of the nerve.
A surgical method developed by the author of this patent application is disclosed in Suture Suspension Arthroplasty Technique for Basal Joint Arthritis Reconstruction, DelSignore and Accardi, to be published in Techniques in Hand and Upper Extremity, December, 2009, which is hereby incorporated by reference. This novel technique avoids tendon harvesting altogether and provides the distinct advantage of utilizing a single small incision (Wagner), which does not cross the wrist flexion crease. It involves a suture suspension (stabilizer) arthroplasty technique, whereby a deep, intra-articular 0 braided polyblended non-absorbable suture is utilized to form a suture suspension sling by anchoring the suture to fixed points of attachments to the flexor carpi radialis insertion and deep ulnar capsule at the base of the index metacarpal, crossing the arthroplasty space and anchoring the radial attachment to the fixed point of insertion of the abductor pollicis longus and dorsal capsule at the dorsal base of the thumb metacarpal. This suture stabilization construct is twice woven back and forth within the arthroplasty space, tightened and firmly sutured over the insertion point of the abductor pollicis longus and dorsal capsule, as longitudinal distraction force and downward (ulnarly-directed) pressure is applied to the metacarpal base. Wrist immobilization is required for only 12-14 days postoperatively, followed by short opponens splinting and active motion, followed by subsequent range of motion and strengthening protocol, with resumption of full use by 3 months postoperatively for the majority of patients. This construct has been shown to effectively stabilize the metacarpal base by tethering it to the index metacarpal via firm anchorage of a heavy non-absorbable suture sling that supports the reconstruction and has been shown to have excellent short-term and long-term, up to 3.5 years, results in the majority of patients, achieving the goals of excellent pain relief, and accurately rebalances the thumb metacarpal with minimal proximal migration (subsidence), excellent restoration of the first webspace angle, and excellent functional recovery with regard to strength and return to activities of daily living. This technique eliminates the specific complications and increased morbidity of the tendon harvesting and transfer procedures and those procedures that require temporary pin fixation or drill holes for tendon passage. This technique does require excessive surgical skill, as it is technically demanding as it requires the skill of back-handed suture passing within a small arthroplasty space. It also requires excision of the entire trapezium to create the suture sling construct and relies on good quality soft tissue for anchorage of the sling.
U.S. Pat. No. 3,496,940 discloses a combined suture and sling for closing an open wound or surgical incision, wherein an elongated strip of flexible hypo-reactive material is formed with a series of integral flexible filaments extending from each longitudinal side edge thereof. The filaments are sewn through the flesh on opposite sides of the wound opening and opposed pairs of filaments are drawn together across the opening and secured to each other to close the wound tightly, with the elongated strip underlying the wound opening and acting as a supporting sling on the under surface of the wound.
U.S. Pat. No. 3,545,008 discloses a tendon prosthesis for use in tendon surgery particularly where there is complete or extensive loss of the tendon, structurally including an elongated member made from a flexible, chemically inert material having at least one flap at each end adapted to overlap the tendon and means for firmly anchoring the prosthesis to the tendon providing a strong, functional anastamotic union.
U.S. Pat. No. 3,805,300 discloses a tendon prosthesis for repair or replacement of a damaged or diseased natural tendon which comprises an elongated member made of biocompatible material having a central portion and two end sections at least one of which has a plurality of longitudinally arranged fenestrations for interweaving with a resected tendon to provide a strong, functional anastomosis. In one embodiment, the second end section of the prosthesis is formed of a pair of flexible cord-like members adapted to anchor the prosthesis to bone structure. In a second embodiment, both end sections include fenestrations allowing each end section to be secured to interwoven segments of a resected tendon.
U.S. Pat. No. 4,187,558 discloses a surgically implantable skeletal ligament having secured thereto at least one deformable collar having a velour-like outer surface adapted to invite tissue ingrowth. In use, the collar portion of the ligament is positioned within a surgically prepared passageway in a bone to protect the ligament from bone abrasion and to assist in ligament attachment by accepting tissue ingrowth into the velour-like surface.
U.S. Pat. No. 4,713,075 discloses a prosthetic device for repairing or replacing connective tissue such as ligaments and tendons in the human or animal body is described. The device comprises a cord of artificial connective tissue formed from a composite, partly absorbable thread. The thread comprises a combination of permanent material and absorbable material susceptible to being dissolved into surrounding living tissue. The dissolving of the absorbable material leaves space for the living tissue to grow into and adhere to the structure formed by the permanent material.
U.S. Pat. No. 4,775,380 discloses a prosthetic ligament for implantation between at least two bones and which takes the form of a tubular body made of woven flexible material through which tissue ingrowth can take place after implantation. A cord is attached to one end of the ligament to thread and to pull the ligament through channels formed in the bones, and a protective detachable sheath is attached to the ligament in order to facilitate the implantation of the ligament as it is pulled through the channels, the sheath immediately thereafter being detached. A bone plug introducer is used to insert a bone plug into one end of the ligament within the bone tunnel, which thereby secures the ligament end in position.
U.S. Pat. No. 6,010,447 discloses a sling device for implant in a human body as a bladder support includes a rectangular, flexible strip of cloth with stiffening members extending across each of the two shorter sides. The stiffening members at each end include a pair of spaced, parallel beams, integrally connected at their ends. Marginal end portions of the flexible strip are passed through the space between the beam around one of the beams, and folded back upon and affixed to the opposing surface of the flexible strip. A flexible suture is attached to a loop at the midpoint of the other beam.
U.S. Pat. No. 6,042,534 relates to prefabricated urethral suspension slings, methods of making the slings, methods of attaching suture to the slings, kits comprising the slings, and methods of using the slings to treat urinary incontinence. The slings comprise a biocompatible material having an elongate shape adapted for urethral suspension. The material has a central portion extending longitudinally between a first end portion and a second end portion. Each end portion of the sling contains at least one suture receiving site. The suture receiving sites are formed prior to surgery and may be reinforced through a variety of means. Sutures may be attached to the suture receiving sites during the manufacturing process or by the physician prior to or during surgery. Additionally, the end portions of the sling containing the suture receiving sites may be thicker than the central portion of the sling.
U.S. Pat. No. 6,110,101 discloses a sling for supporting the urethra and neck of the bladder to prevent urinary incontinence is disclosed. The sling is designed to provide sufficient support to inhibit the unintended flow of urine, yet stretch in a controlled fashion so that the bladder can be voided at approximate times.
U.S. Pat. No. 6,517,578 describes a graft suspension device for suspending a ligament in a bone hole. The suspension device comprises a first loop and second loop suspended from an anchor and has a cradle at the opposite end of the loop to the anchor. Ligament grafts are looped over the cradle and loose ends may be pulled by finger loops whereby the surgeon can adjust the distance of the cradle from the anchor thereby tensioning the grafts as desired.
U.S. Pat. No. 6,872,227 discloses a strip-like implant that has a tape with a first end and with a second end. In the area of at least one of the two ends, a disk-like application aid aligned with the plane of the tape is arranged. The disk-like application aid can also be constructed in the shape of two jaws of a surgical gripping instrument which is set up to grip an implant tape.
U.S. Pat. No. 7,083,568 discloses an implantable article and method of use are disclosed to treat urological disorders. The biocompatible device includes a sling assembly configured to be minimally invasive and provide sufficient support to the target site. In addition, the configuration of the sling assembly also allows the position of the sling to be permanently changed during and/or after implantation.
U.S. Publication No. 2002/0019670 discloses an implantable tissue augmentation device having a multiplicity of biocompatible strands, each of said strands having at least one end wherein the multiplicity of strands are integrally joined at the at least one end of each of the multiplicity of strands. Optionally, the augmentation device has an attachment feature allowing easy attachment to a suture, a needle or other surgical instrument. The strands can have various cross sectional configurations such as rectangles or polygons.
U.S. Publication No. 2002/0123750 relates to orthopedic implants made from a mesh material. The mesh material can be treated in order to promote bone growth, to provide antibiotics, or to provide other beneficial treatment. Specific applications for the implants include, for example, a prosthetic ligament, a tension band, an interbody device, or a fixation device that extends across one or more joints or fractures.
U.S. Publication No. 2006/0149261 discloses a spacer member that is intended to be placed between the ends of the bones which are to be connected, one end of the spacer member being designed to form a joint surface against one of the bone ends. A joint-stabilizing connection is arranged to connect the bones. The spacer member is made of at least one tissue-compatible material.
U.S. Publication No. 2006/0241617 discloses a bone plate and method of forming a bone plate having a plurality of suture loops pre-attached to the bone plate. The suture loops may be flexible and formed of a strong suture material. The suture loops may have various shapes, forms and configurations and may be provided on the bone plate in any number, depending on the characteristics of the fractured bone or bone segments, or of the plate design. Preferably, the suture loops are attached to a surface of the bone plate. The suture loops may receive a strand of suture for fixation of soft tissue to the bone plate.
U.S. Publication No. 2009/0018655 discloses a biocompatible implants that combine a scaffold material for supporting long term repair of a soft tissue with an elongated member such as a suture for aiding in placement of the scaffold during a surgical procedure as well as for immediate mechanical reinforcement of a repair site. The components of an implant are combined such that a longitudinal load placed upon a composite structure can be borne primarily by the elongated member and the scaffold material is isolated from the longitudinal load. Thus, the scaffold material of a composite can be protected from damage due to applied loads and stresses during and following a surgical procedure.
PCT Publication No. WO 2006/034719 discloses a stent which is composed of an external rigid skeleton shaped like an incurving rectangle made of the organically inert substance (Polypropylene). The area in the center or the inside area of the skeleton is filled with a macroporous polypropylene mesh (pores>78 um). Fixed to each of the four corners of the stent is a surgical thread (3) made of Polydioxanone (PDS) number Zero (1-0) with a swaged on curved needle. The stent is of two different sizes to accommodate variations in vaginal capacity. The large measures: 9 cm in length, 5 cm in width and 5 mm in thickness. The small measures: 7 cm in length, 3.5 cm in width and 3.5 mm in thickness.
PCT Publication No. WO 2007/002071 discloses surgical procedures, kits and implants for alleviating human incontinence, and particularly providing improved methods and apparatus to secure a urethral sling to pubic bone to support the urethra and alleviate incontinence are disclosed. Bone anchors are driven into pubic bones with elongated bone anchor sutures configured to be passed through openings of a urethral sling. Suture retainers are applied to the sutures to apply retentive force to the urethral sling to maintain the fixation of the urethral sling proximate to the pubic bone.
Existing surgical devices and methodology, as described above, exhibit several unique drawbacks and disadvantages. In the case of artificial joint replacement surgery, several complications may be encountered; including fracture, bosening, subluxation or dislocation, particulate synovitis and other reported complications that may result in eventual failure of the implant. Additionally, surgical implants designed for other parts of the human body have been difficult to adapt to basal joint arthroplasty, due to the complex nature of the anatomy of the basal joint, the arthritic deformity of subluxation and adduction contracture that occurs with progression of basal joint arthritis, and the cantilever forces applied across the metacarpal base. More complex soft tissue reconstructive methods for basal joint arthroplasty can be associated with the potential for greater short and occasionally long-term impairment of the hand, requiring prolonged rehabilitation. Many of these methods involve more extensive (and at times multiple) surgical incisions, sacrificing normal tendons that are utilized to stabilize the basal joint after trapeziectomy and must be re-directed via bone drill holes to support the thumb metacarpal base. The abductor pollicis longus suspensionplasty technique as disclosed in the American Society for Surgery of the Hand Correspondence Newsletter, DelSignore, 2004-52, August, 2004 eliminates the need to re-direct a tendon through a drill hole, but does sacrifice a slip of the abductor pollicis longus tendon and utilizes an incision which crosses proximal to the wrist flexion crease, requiring immobilization for 4 weeks and thus can be associated with increased morbidity of wrist stiffness and longer recovery, as seen with the other soft tissue tendon-sacrificing techniques. In order to successfully reconstruct an advanced stage arthritic basal joint, all arthritic surfaces must be addressed. The important volar oblique ligament function must be restored, the base of the thumb metacarpal must be approximated close to the base of the index metacarpal, thereby regaining and improving first webspace abduction angle, and the joint arthroplasty space should be preserved to prevent proximal migration and subsequent weakness and collapse deformity. With the utilization of the basal joint stabilizer sling, these goals can be accomplished, with less morbidity, smaller incision, shorter operative time, less demanding surgical technique, and faster short term recovery with earlier resumption of activities of daily living.